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Last Updated: January 19, 2021

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LAMOTRIGINE Drug Profile

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Which patents cover Lamotrigine, and what generic alternatives are available?

Lamotrigine is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Par Pharm, Rubicon, Torrent, Wockhardt Ltd, Zydus Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Celltrion, Cipla, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, and Zydus Pharms Usa. and is included in forty-seven NDAs.

The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

US ANDA Litigation and Generic Entry Outlook for Lamotrigine

A generic version of LAMOTRIGINE was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.

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Paragraph IV (Patent) Challenges for LAMOTRIGINE
Tradename Dosage Ingredient NDA Submissiondate
LAMICTAL XR TABLET, EXTENDED RELEASE;ORAL lamotrigine 022115 2014-02-12
LAMICTAL ODT TABLET, ORALLY DISINTEGRATING;ORAL lamotrigine 022251 2009-12-21
LAMICTAL TABLET;ORAL lamotrigine 020241
LAMICTAL CD TABLET, CHEWABLE;ORAL lamotrigine 020764

US Patents and Regulatory Information for LAMOTRIGINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 207763-006 Apr 1, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Celltrion LAMOTRIGINE lamotrigine TABLET;ORAL 078982-001 Jan 27, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Anchen Pharms LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 201374-006 Dec 26, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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